We are delighted to announce that Astor Bannerman has just achieved ISO13485 accreditation, an internationally agreed standard specific to the medical devices industry. We are extremely proud of our strong in-house quality management systems and are pleased that we now have independent endorsement of our processes and procedures, all of which put innovation and customer safety at their heart.

We have had the more general ISO9001 accreditation for many years, but in 2021 decided to start the process of achieving ISO13485 as its requirements are more specific to the market in which we operate and the equipment we manufacture – namely products designed for disabled people where safety and effectiveness are paramount.

This important accreditation adds to our suite of industry recognised standards, including Constructionline (Gold Member), CHAS and Acclaim.

ISO 13485 is the quality management system standard for medical device manufacturers and their sub-tier suppliers and subcontractors. Based on the ISO 9001 standard, ISO 13485 includes additional requirements for medical device manufacturers to demonstrate their intent to comply with applicable regulatory and statutory requirements. ISO 13485 is recognized as an aid in supporting compliance with the Medical Device Directive.

ISO 13485 helps an organisation design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.

Mark Colebrook, Astor Bannerman’s Managing Director said of the news: